Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial
<p>Abstract</p> <p>Background</p> <p>Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2013-01-01
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| Series: | BMC Neurology |
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| Online Access: | http://www.biomedcentral.com/1471-2377/13/11 |
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| author | Leistner Stefanie Michelson Georg Laumeier Inga Ahmadi Michael Smyth Maureen Nieweler Gabriele Doehner Wolfram Sobesky Jan Fiebach Jochen B Marx Peter Busse Otto Köhler Friedrich Poppert Holger Wimmer Martin LJ Knoll Thomas Von Weitzel-Mudersbach Paul Audebert Heinrich J |
| author_facet | Leistner Stefanie Michelson Georg Laumeier Inga Ahmadi Michael Smyth Maureen Nieweler Gabriele Doehner Wolfram Sobesky Jan Fiebach Jochen B Marx Peter Busse Otto Köhler Friedrich Poppert Holger Wimmer Martin LJ Knoll Thomas Von Weitzel-Mudersbach Paul Audebert Heinrich J |
| author_sort | Leistner Stefanie |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA.</p> <p>Methods/design</p> <p>Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program) and control (usual care) arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients’ motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out).</p> <p>Discussion</p> <p>Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed.</p> <p>Trial registration</p> <p>clinicaltrials.gov: 01586702</p> |
| first_indexed | 2024-12-10T16:12:05Z |
| format | Article |
| id | doaj.art-fbfcfd07b06641e7ba7a8e1740500dc6 |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-12-10T16:12:05Z |
| publishDate | 2013-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-fbfcfd07b06641e7ba7a8e1740500dc62022-12-22T01:42:05ZengBMCBMC Neurology1471-23772013-01-011311110.1186/1471-2377-13-11Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trialLeistner StefanieMichelson GeorgLaumeier IngaAhmadi MichaelSmyth MaureenNieweler GabrieleDoehner WolframSobesky JanFiebach Jochen BMarx PeterBusse OttoKöhler FriedrichPoppert HolgerWimmer Martin LJKnoll ThomasVon Weitzel-Mudersbach PaulAudebert Heinrich J<p>Abstract</p> <p>Background</p> <p>Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA.</p> <p>Methods/design</p> <p>Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program) and control (usual care) arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients’ motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out).</p> <p>Discussion</p> <p>Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed.</p> <p>Trial registration</p> <p>clinicaltrials.gov: 01586702</p>http://www.biomedcentral.com/1471-2377/13/11TIAStrokeSecondary preventionIntervention trial |
| spellingShingle | Leistner Stefanie Michelson Georg Laumeier Inga Ahmadi Michael Smyth Maureen Nieweler Gabriele Doehner Wolfram Sobesky Jan Fiebach Jochen B Marx Peter Busse Otto Köhler Friedrich Poppert Holger Wimmer Martin LJ Knoll Thomas Von Weitzel-Mudersbach Paul Audebert Heinrich J Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial BMC Neurology TIA Stroke Secondary prevention Intervention trial |
| title | Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial |
| title_full | Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial |
| title_fullStr | Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial |
| title_full_unstemmed | Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial |
| title_short | Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial |
| title_sort | intensified secondary prevention intending a reduction of recurrent events in tia and minor stroke patients inspire tms a protocol for a randomised controlled trial |
| topic | TIA Stroke Secondary prevention Intervention trial |
| url | http://www.biomedcentral.com/1471-2377/13/11 |
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